Job Purpose
Lead and manage overall site operations for the Injectable Manufacturing Facility, ensuring excellence in Manufacturing, Packaging, Warehouse, PPIC, Engineering, Compliance, Quality, Safety, and Business Performance.
Key Responsibilities
- Drive overall plant performance and ensure achievement of production, quality, compliance, delivery, and business targets.
- Oversee Manufacturing, Packaging, Warehouse, PPIC (Production Planning & Inventory Control), and Engineering operations.
- Ensure effective production planning, material availability, inventory optimization, and on-time customer deliveries.
- Provide strategic and operational leadership to ensure efficient site operations and optimum resource utilization.
- Coordinate with Project Management teams on plant expansion, technology upgrades, and critical projects.
- Collaborate with R&D for technology transfer, scale-up, validation, and commercialization activities.
- Ensure compliance with cGMP requirements and maintain audit readiness for global regulatory agencies, including USFDA.
- Lead client visits, customer audits, and regulatory inspections.
- Work closely with QA, QC, Supply Chain, Engineering, and other cross-functional teams to achieve organizational objectives.
- Manage budgets, operational costs, and capital expenditure plans.
- Drive continuous improvement, productivity enhancement, cost optimization, and operational excellence initiatives.
- Develop high-performing teams and foster a culture of accountability, compliance, quality, and safety.
Qualifications & Experience
- Bachelor's/Master's degree in Pharmacy, Engineering, or related discipline.
- 20+ years of experience in pharmaceutical manufacturing, with significant exposure to Sterile/Injectable Operations.
- Proven experience in leading large-scale manufacturing facilities with responsibility for end-to-end plant operations.
- Strong exposure to global regulatory audits, including USFDA, MHRA, EU GMP, and other international agencies.
Key Competencies
- Plant Leadership
- Injectable Manufacturing Operations
- PPIC & Supply Chain Management
- Regulatory Compliance
- Project Management
- Strategic Planning
- Budget & Resource Management
- Stakeholder Management
- Team Development & Leadership